Efficacy of Banhasasim-tang on Functional Dyspepsia

NCT ID: NCT00987805

Last Updated: 2012-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2011-01-31

Brief Summary

The purpose of this study is to assess efficacy based on Gastrointestinal Symptom score and safety based on the rate of adverse event or laboratory findings of Banhasasim-tang administrated three times a day orally on functional dyspepsia.

Detailed Description

Banhasasim-tang

1. Main 3 gram herb powder (including Rhizoma Pinelliae, Radix Scutellariae, Zingiberis Rhizoma, Panax ginseng, Glycyrrhiza uralensis Fisch, Zizyphi Fructus and Coptidis Rhizoma) of old oriental prescriptions for dyspepsia.

2. Usually having used for dyspepsia in asia

3. Need for correct clinical information by RCT

Conditions

Functional Dyspepsia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Banhasasim-tang

Group Type: EXPERIMENTAL

Banhasasim-tang

Intervention Type: DIETARY_SUPPLEMENT

Form : granules Contents : It consists of seven Herbs. It contains Rhizoma Pinelliae, Radix Scutellariae, Zingiberis Rhizoma, Panax ginseng, Glycyrrhiza uralensis Fisch, Zizyphi Fructus and Coptidis Rhizoma Dosage and frequency : 9g per day (three times a day) Route of administration : Oral Administration duration : 42 days in the study

Placebo drug

The placebo of this study is corn-starch granules. It has the same form, color, flavor and amount like experimental herbal extracted formula

Group Type: PLACEBO_COMPARATOR

Corn-starch granules

Intervention Type: DIETARY_SUPPLEMENT

This placebo has the same form, color, and flavor as experimental intervention.The dosage, frequency and duration is also same as experimental intervention.

Interventions

Banhasasim-tang

Form : granules Contents : It consists of seven Herbs. It contains Rhizoma Pinelliae, Radix Scutellariae, Zingiberis Rhizoma, Panax ginseng, Glycyrrhiza uralensis Fisch, Zizyphi Fructus and Coptidis Rhizoma Dosage and frequency : 9g per day (three times a day) Route of administration : Oral Administration duration : 42 days in the study

Intervention Type: DIETARY_SUPPLEMENT

Corn-starch granules

This placebo has the same form, color, and flavor as experimental intervention.The dosage, frequency and duration is also same as experimental intervention.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Brand names : Bansasin granules; Corn-starch granules with herb decoctions flavor

Eligibility Criteria

Inclusion Criteria

1. Typical functional dyspepsia according to ROME III criteria.

• One or more of:

• Bothersome post-prandial fullness
• Early satiation
• Epigastric pain
• Epigastric burning
• No evidence of structural disease (including at upper endoscopy) that is likely to explain the symptoms

2. The presence of 'moderate' as the degree of severity for at least three Gastrointestinal Symptom (GIS) score symptoms

3. Before participation of trial, epigastric pain or discomfort has persisted in a permanent or recurrent form for a minimum period of 12 weeks

4. Written and informed consent

Exclusion Criteria

1. History of peptic ulcer or gastroesophageal reflux disease(GERD)

2. Current prominent symptoms of irritable bowel syndrome or GERD

3. Presence of the following alarm symptoms:

• Severe weight loss
• Black or tar stool
• Dysphagia

4. Presence of the following diseases (like cholangitis, pancreatitis, etc.) or uncontrolled severe organ disorders

5. Women in pregnancy and lactation

6. History of gastrointestinal surgery or taking any drugs that may significantly alter digestive system

7. Participation of other clinical trials within the last 3 months

8. Severe mental problems or drug abuse

9. Judged by expert that they are appropriate to participate in this study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Korea Health Industry Development Institute

OTHER_GOV

Sponsor Role: lead

Responsible Party

Jin-sung Kim

Full professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jin-sung Kim, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Kyung Hee University Medical Center Oriental Hospital

Locations

Kyung Hee University Medical Center Oriental Hospital

Seoul, , South Korea

East-West Neo Medical Center

Seoul, , South Korea

Countries

South Korea

References

Park JW, Ryu B, Yeo I, Jerng UM, Han G, Oh S, Lee J, Kim J. Banha-sasim-tang as an herbal formula for the treatment of functional dyspepsia: a randomized, double-blind, placebo-controlled, two-center trial. Trials. 2010 Jul 30;11:83. doi: 10.1186/1745-6215-11-83.

Reference Type: DERIVED

PMID: 20670451 (View on PubMed)

Other Identifiers

ISRCTN51910678

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

B090029

Identifier Type: -

Identifier Source: org_study_id